Department of Health & CMS Manual System Human Services (DHHS) Pub 100-04 Medicare Claims Processing Centers for Medicare & Medicaid Services (CMS) Transmittal 2255 Date: July 15, 2011 Change Request 7476

SUBJECT: Quarterly Update to the End-Stage Renal Disease Prospective Payment System

I. SUMMARY OF CHANGES: This change request corrects Attachment 4 and Attachment 5 of change request 7064, Transmittal 2134, by removing equipment and supply codes from Attachment 4 that are either not separately payable or not payable by Medicare and adds these codes to Attachment 5. This change request also updates Attachment 8 of change request 7064 which includes the ICD-9-CM codes eligible for the ESRD PPS co-morbidity payment adjustment. This Recurring Update Notification applies to Chapter 8, Section 20.1.

EFFECTIVE DATE: The effective date for the ICD-9-CM updates is October 1, 2011 The effective date for the DME list corrections is January 1, 2011 IMPLEMENTATION DATE: October 3, 2011

Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated) R=REVISED, N=NEW, D=DELETED-

R/N/D CHAPTER / SECTION / SUBSECTION / TITLE N/A

III. FUNDING: For Fiscal Intermediaries (FIs), Regional Home Health Intermediaries (RHHIs) and/or Carriers: No additional funding will be provided by CMS; Contractor activities are to be carried out within their operating budgets.

For Medicare Administrative Contractors (MACs): The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions regarding continued performance requirements.

IV. ATTACHMENT:

Recurring Update Notification

*Unless otherwise specified, the effective date is the date of service. Attachment – Recurring Update Notification

Pub. 100-04 Transmittal: 2255 Date: July 15, 2011 Change Request: 7476

SUBJECT: Quarterly Update to the End-Stage Renal Disease Prospective Payment System

Effective Date: The effective date for the ICD-9-CM updates is October 1, 2011 The effective date for the DME list corrections is January 1, 2011

Implementation Date: October 3, 2011

I. GENERAL INFORMATION

A. Background: Change Request (CR) 7064, Transmittal 2134, entitled “End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Consolidated Billing for Limited Part B Services” implemented a new bundled payment system for renal dialysis items and services provided on and after January 1, 2011 (See Transmittal 2134, Pub. 100-04, issued on January 14, 2011.). The ESRD PPS provides payment adjustments for 6 categories (3 acute and 3 chronic) of co-morbid conditions. When applicable, ESRD facilities can report specific ICD-9-CM diagnosis codes (codes effective January 1, 2011, can be found in attachment 8 of CR 7064) on ESRD facility claims to be eligible for a co-morbidity payment adjustment. The ICD-9-CM codes are updated annually as stated in Pub. 100-04, Chapter 23, Section 10.2 and are published in the Federal Register in April/May of each year as part of the Proposed Changes to the Hospital Inpatient Prospective Payment Systems in table 6 and effective each October 1. This CR updates attachment 8 of CR 7064 which includes the ICD-9-CM codes eligible for the ESRD PPS co- morbidity payment adjustment in accordance to the annual ICD-9-CM update which is effective October 1, 2011.

CR 7064 also provided an ESRD consolidated billing requirement for limited Part B services included in the ESRD facility bundled payment. CR 7064 instructed contractors that certain lab services and limited drugs, equipment and supplies are subject to Part B consolidated billing and are no longer separately payable when provided to ESRD beneficiaries by providers other than the ESRD facilities.

Attachment 4 of CR 7064, DME ESRD Supply HCPCS for ESRD PPS Consolidated Billing Edits, included the list of equipment and supplies that are ESRD-related but can be used in other provider settings for reasons other than for the treatment of ESRD. Attachment 5 of CR 7064, DME ESRD Supply HCPCS Not Payable to DME Suppliers, included the list of the DME ESRD supply codes that are no longer separately payable to durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers. To allow DMEPOS suppliers to get paid for furnishing these services under other circumstances covered by Medicare, CR 7064 provided instructions stating that DMEPOS suppliers may bill the items listed on Attachment 4 with the AY modifier to indicate that the item is used for reasons other than for the treatment of ESRD. Currently, there are equipment and supplies listed on Attachment 4 that are not used in other provider settings and would therefore never be used for reasons other than for the treatment of ESRD. Therefore, these items would not be covered by Medicare because there is no other benefit category that can provide coverage. This CR rescinds and replaces Attachments 4 and 5 of CR 7064. This CR removes codes from Attachment 4 that are either not separately payable or not payable by Medicare and add these codes to Attachment 5. Surgical dressing code A6204 will also be included in Attachment 5.

B. Policy:

The updated list of ICD-9-CM codes that are eligible for a co-morbidity payment adjustment under the ESRD PPS will be available at the following website: http://www.cms.gov/ESRDPayment/40_Comorbidity_Conditions.asp#TopOfPage .

The updated diagnosis codes are effective for dates of service on and after October 1, 2011. In this CR we are not adding nor changing any additional co-morbidity categories or any diagnoses within those categories.

Changes to the ICD-9-CM codes that are eligible for a co-morbidity payment adjustment effective October 1, 2011 include:

1. In the chronic comorbid conditions under the hereditary hemolytic and sickle cell anemia category, ICD-9 code 282.41 – Sickle-cell thalassemia without crisis has been revised to include microdrepanocytosis.

2. In the chronic comorbid conditions under the hereditary hemolytic and sickle cell anemia category, the 5 new ICD-9 codes added are as follows: - 282.43 Alpha thalassemia Alpha thalassemia major Hemoglobin H Constant Spring Hemoglobin H disease Hydrops fetalis due to alpha thalassemia Severe alpha thalassemia Triple gene defect alpha thalassemia

Excludes: alpha thalassemia trait or minor (282.46); hydrops fetalis due to isoimmunization (773.3); hydrops fetalis not due to immune hemolysis (778.0)

- 282.44 Beta thalassemia Beta thalassemia major Cooley’s anemia Homozygous beta thalassemia Severe beta thalassemia Thalassemia intermedia Thalassemia major

Excludes: beta thalassemia minor (282.46); beta thalassemia trait (282.46); delta-beta thalassemia (282.45); hemoglobin E beta thalassemia (282.47); sickle-cell beta thalassemia (282.41, 282.42)

- 282.45 Delta-beta thalassemia Homozygous delta-beta thalassemia

Excludes: delta-beta thalassemia trait (282.46)

- 282.46 Thalasesmia minor Alpha thalassemia minor Alpha thalassemia trait Alpha thalassemia silent carrier Beta thalassemia minor Beta thalassemia trait Delta-beta thalassemia trait Thalassemia trait NOS

Excludes: alpha thalassemia (282.43); beta thalassemia (282.44); delta beta thalassemia (282.45); hemoglobin E-beta thalassemia (282.47); sickle-cell trait (282.5)

- 282.47 Hemoglobin E-beta thalassemia

Excludes: beta thalassemia (282.44); beta thalassemia minor (282.46); beta thalassemia trait (282.46); delta-beta thalassemia (282.45); delta-beta thalassemia trait (282.46); hemoglobin E disease (282.7); other hemoglobinopathies (282.7); sickle-cell beta thalassemia (282.41, 282.42)

3. In the chronic comorbid conditions under the hereditary hemolytic and sickle cell anemia category, ICD-9 code 282.49 – Other thalassemia has been revised to no longer include Cooley's anemia, Hb-Bart's disease, Microdrepanocytosis, Thalassemia (alpha) (beta) (intermedia) (major) (minima) (minor) (mixed) (trait), and Thalassemia NOS.

4. In the chronic comorbid conditions under hereditary hemolytic and sickle cell anemia category, ICD-9 code 282.49 – Other thalassemia has been revised to include Dominant thalassemia, Hemoglobin C thalassemia, Mixed thalassemia, and continues to include Thalassemia with other hemoglobinopathy.

5. In the chronic comorbid conditions under hereditary hemolytic and sickle cell anemia category, ICD-9 code 282.49 – Other thalassemia has been revised to exclude hemoglobin C disease (282.7); hemoglobin E disease (282.7); other hemoglobinopathies (282.7); sickle cell anemias (282.60-282.69); and sickle-cell beta thalassemia (282.41-282.42)

In addition, this CR provides updated lists of HCPCS codes subject to ESRD consolidated billing (Attachment 4) and DME ESRD supply HCPCS codes not payable to DMEPOS suppliers (Attachment 5). Contractors shall use the revised lists in adjudicating claims submitted by DMEPOS suppliers, using the guidelines established in CR 7064.

II. BUSINESS REQUIREMENTS TABLE

Number Requirement Responsibility (place an “X” in each applicable column) A D F C R Shared- OTHER / M I A H System B E R H Maintainers R I M M I A A E C C R F M V C I C M W S S S F S 7476.1 Contractors shall add 5 new ICD-9 codes to the list of X ICD-9 codes eligible for the ESRD PPS co-morbidity payment adjustment for the chronic comorbid condition hereditary hemolytic sickle cell anemia category (payer only condition code ME)

ADD ICD-9 Codes: 282.43 282.44 282.45 282.46 Number Requirement Responsibility (place an “X” in each applicable column) A D F C R Shared- OTHER / M I A H System B E R H Maintainers R I M M I A A E C C R F M V C I C M W S S S F S 282.47 7476.2 Contractors shall update the ESRD consolidated billing X X list for DMEPOS suppliers 7476.2.1 Contractors shall refer to Attachment 4 for an updated X X list of ESRD HCPCS codes subject to ESRD CB. 7476.2.2 Contractors shall refer to Attachment 5 for an updated X X list of ESRD HCPCS codes that are not subject to ESRD CB. 7476.3 Contractors shall use the revised lists referenced above X X in adjudicating claims submitted by DMEPOS suppliers, using the guidelines established in CR 7064. 7476.4 Contractors shall adjust claims brought to their X attention. NOTE: contactors do not need to search their files to either retract payment for claims already paid or to retroactively pay claims. 7476.5 Contractors shall note the appropriate ICD-10 code(s) X that are listed below. Contractors shall track the ICD-10 codes and ensure that the update occurs as part of the ICD-10 implementation. ICD-10 equivalents that are available are provided below and are effective on October 1, 2013.

ICD-9 ICD-10 282.43 D56.0 282.44 D56.1 282.45 D56.2 282.46 D56.3 282.47 Not available at this time

III. PROVIDER EDUCATION TABLE

Number Requirement Responsibility (place an “X” in each applicable column) A D F C R Shared- OTHER / M I A H System B E R H Maintainers R I F M V C M M I I C M W A A E S S S F C C R S 7476.6 A provider education article related to this instruction will X X X be available at http://www.cms.hhs.gov/MLNMattersArticles/ shortly after the CR is released. You will receive notification of the article release via the established "MLN Matters" listserv. Contractors shall post this article, or a direct link to this article, on their Web site and include information about it in a listserv message within one week of the availability of the provider education article. In addition, the provider education article shall be included in your next regularly scheduled bulletin. Contractors are free to supplement MLN Matters articles with localized information that would benefit their provider community in billing and administering the Medicare program correctly.

IV. SUPPORTING INFORMATION

Section A: For any recommendations and supporting information associated with listed requirements, use the box below:

X-Ref Recommendations or other supporting information: Requirement Number 7476.2 Attachments 4 and 5 of CR7064 are rescinded and replaced by the attached lists of Healthcare Common Procedure Coding System (HCPCS) codes. Contractors shall use the updated lists to determine the items that may be billed separately by DMEPOS suppliers under the guidelines established in CR 7064.

Section B: For all other recommendations and supporting information, use this space: N/A

V. CONTACTS

Pre-Implementation Contact(s): For ESRD PPS payment policy questions, please contact Michelle Cruse at [email protected]. For institutional claims processing questions, please contact Wendy Tucker at [email protected]. For DME claims processing questions, please contact Bobbett Plummer at [email protected]. For DME payment policy questions, please contact Hafsa Bora at [email protected].

Post-Implementation Contact(s): Contact your Contracting Officer’s Technical Representative (COTR) or Contractor Manager, as applicable.

VI. FUNDING

Section A: For Fiscal Intermediaries (FIs), Regional Home Health Intermediaries (RHHIs), and/or Carrier: No additional funding will be provided by CMS; contractor activities are to be carried out within their operating budgets.

Section B: For Medicare Administrative Contractors (MACs), include the following statement: The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions regarding continued performance requirements.

Attachment Attachment 4: DME ESRD Supply HCPCS for ESRD PPS Consolidated Billing Edits

HCPC Long Description

STERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, A4216 10 ML

A4217 STERILE WATER/SALINE, 500 ML A4218 STERILE SALINE OR WATER, METERED DOSE DISPENSER, 10 ML A4450 TAPE, NON-WATERPROOF, PER 18 SQUARE INCHES A4452 TAPE, WATERPROOF, PER 18 SQUARE INCHES A6215 FOAM DRESSING, WOUND FILLER, STERILE, PER GRAM GAUZE, NON-IMPREGNATED, STERILE, PAD SIZE 16 SQ. IN. OR A6402 LESS, WITHOUT ADHESIVE BORDER, EACH DRESSING E0210 ELECTRIC HEAT PAD, STANDARD

Attachment 5: DME ESRD Supply HCPCS Not Payable to DME Suppliers

HCPC Long Description

A4215 NEEDLE, STERILE, ANY SIZE, EACH A4244 ALCOHOL OR PEROXIDE, PER PINT A4245 ALCOHOL WIPES, PER BOX A4246 BETADINE OR PHISOHEX SOLUTION, PER PINT A4247 BETADINE OR IODINE SWABS/WIPES, PER BOX A4248 CHLORHEXIDINE CONTAINING ANTISEPTIC, 1 ML A4651 CALIBRATED MICROCAPILLARY TUBE, EACH A4652 MICROCAPILLARY TUBE SEALANT PERITONEAL DIALYSIS CATHETER ANCHORING DEVICE, A4653 BELT, EACH

A4657 SYRINGE, WITH OR WITHOUT NEEDLE, EACH SPHYGMOMANOMETER/BLOOD PRESSURE APPARATUS A4660 WITH CUFF AND STETHOSCOPE

A4663 BLOOD PRESSURE CUFF ONLY

A4670 AUTOMATIC BLOOD PRESSURE MONITOR DISPOSABLE CYCLER SET USED WITH CYCLER DIALYSIS A4671 MACHINE, EACH A4672 DRAINAGE EXTENSION LINE, STERILE, FOR DIALYSIS, EACH EXTENSION LINE WITH EASY LOCK CONNECTORS, USED A4673 WITH DIALYSIS CHEMICALS/ANTISEPTICS SOLUTION USED TO A4674 CLEAN/STERILIZE DIALYSIS EQUIPMENT, PER 8 OZ A4680 ACTIVATED CARBON FILTER FOR HEMODIALYSIS, EACH DIALYZER (ARTIFICIAL KIDNEYS), ALL TYPES, ALL SIZES, A4690 FOR HEMODIALYSIS, EACH BICARBONATE CONCENTRATE, SOLUTION, FOR A4706 HEMODIALYSIS, PER GALLON BICARBONATE CONCENTRATE, POWDER, FOR A4707 HEMODIALYSIS, PER PACKET ACETATE CONCENTRATE SOLUTION, FOR HEMODIALYSIS, A4708 PER GALLON ACID CONCENTRATE, SOLUTION, FOR HEMODIALYSIS, PER A4709 GALLON TREATED WATER (DEIONIZED, DISTILLED, OR REVERSE A4714 OSMOSIS) FOR PERITONEAL DIALYSIS, PER GALLON A4719 "Y SET" TUBING FOR PERITONEAL DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 249CC, BUT A4720 LESS THAN OR EQUAL TO 999CC, FOR PERITONEAL DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 999CC BUT LESS A4721 THAN OR EQUAL TO 1999CC, FOR PERITONEAL DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 1999CC BUT LESS THAN OR EQUAL TO 2999CC, FOR PERITONEAL A4722 DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 2999CC BUT LESS THAN OR EQUAL TO 3999CC, FOR PERITONEAL A4723 DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 3999CC BUT LESS THAN OR EQUAL TO 4999CC, FOR PERITONEAL A4724 DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 4999CC BUT LESS THAN OR EQUAL TO 5999CC, FOR PERITONEAL A4725 DIALYSIS DIALYSATE SOLUTION, ANY CONCENTRATION OF DEXTROSE, FLUID VOLUME GREATER THAN 5999CC, FOR A4726 PERITONEAL DIALYSIS DIALYSATE SOLUTION, NON-DEXTROSE CONTAINING, 500 A4728 ML A4730 FISTULA CANNULATION SET FOR HEMODIALYSIS, EACH A4736 TOPICAL ANESTHETIC, FOR DIALYSIS, PER GRAM A4737 INJECTABLE ANESTHETIC, FOR DIALYSIS, PER 10 ML A4740 SHUNT ACCESSORY, FOR HEMODIALYSIS, ANY TYPE, EACH BLOOD TUBING, ARTERIAL OR VENOUS, FOR A4750 HEMODIALYSIS, EACH BLOOD TUBING, ARTERIAL AND VENOUS COMBINED, FOR A4755 HEMODIALYSIS, EACH DIALYSATE SOLUTION TEST KIT, FOR PERITONEAL A4760 DIALYSIS, ANY TYPE, EACH DIALYSATE CONCENTRATE, POWDER, ADDITIVE FOR A4765 PERITONEAL DIALYSIS, PER PACKET DIALYSATE CONCENTRATE, SOLUTION, ADDITIVE FOR A4766 PERITONEAL DIALYSIS, PER 10 ML A4770 BLOOD COLLECTION TUBE, VACUUM, FOR DIALYSIS, PER 50 A4771 SERUM CLOTTING TIME TUBE, FOR DIALYSIS, PER 50 A4772 BLOOD GLUCOSE TEST STRIPS, FOR DIALYSIS, PER 50 A4773 OCCULT BLOOD TEST STRIPS, FOR DIALYSIS, PER 50 A4774 AMMONIA TEST STRIPS, FOR DIALYSIS, PER 50 A4802 PROTAMINE SULFATE, FOR HEMODIALYSIS, PER 50 MG DISPOSABLE CATHETER TIPS FOR PERITONEAL DIALYSIS, A4860 PER 10 PLUMBING AND/OR ELECTRICAL WORK FOR HOME A4870 HEMODIALYSIS EQUIPMENT CONTRACTS, REPAIR AND MAINTENANCE, FOR A4890 HEMODIALYSIS EQUIPMENT A4911 DRAIN BAG/BOTTLE, FOR DIALYSIS, EACH MISCELLANEOUS DIALYSIS SUPPLIES, NOT OTHERWISE A4913 SPECIFIED A4918 VENOUS PRESSURE CLAMP, FOR HEMODIALYSIS, EACH A4927 GLOVES, NON-STERILE, PER 100 A4928 SURGICAL MASK, PER 20 A4929 TOURNIQUET FOR DIALYSIS, EACH A4930 GLOVES, STERILE, PER PAIR A4931 ORAL THERMOMETER, REUSABLE, ANY TYPE, EACH A6204 SURGICAL DRESSING SKIN SEALANTS, PROTECTANTS, MOISTURIZERS, A6250 OINTMENTS, ANY TYPE, ANY SIZE A6260 WOUND CLEANSERS, STERILE, ANY TYPE, ANY SIZE E1500 CENTRIFUGE, FOR DIALYSIS KIDNEY, DIALYSATE DELIVERY SYST. KIDNEY MACHINE, PUMP RECIRCULAT- ING, AIR REMOVAL SYST, FLOWRATE METER, POWER OFF, HEATER AND TEMPERATURE CONTROL WITH ALARM, I.V.POLES, PRESSURE GAUGE, CONCENTRATE E1510 CONTAINER E1520 HEPARIN INFUSION PUMP FOR HEMODIALYSIS AIR BUBBLE DETECTOR FOR HEMODIALYSIS, EACH, E1530 REPLACEMENT PRESSURE ALARM FOR HEMODIALYSIS, EACH, E1540 REPLACEMENT E1550 BATH CONDUCTIVITY METER FOR HEMODIALYSIS, EACH BLOOD LEAK DETECTOR FOR HEMODIALYSIS, EACH, E1560 REPLACEMENT E1570 ADJUSTABLE CHAIR, FOR ESRD PATIENTS TRANSDUCER PROTECTORS/FLUID BARRIERS, FOR E1575 HEMODIALYSIS, ANY SIZE, PER 10 E1580 UNIPUNCTURE CONTROL SYSTEM FOR HEMODIALYSIS E1590 HEMODIALYSIS MACHINE AUTOMATIC INTERMITTENT PERITIONEAL DIALYSIS E1592 SYSTEM E1594 CYCLER DIALYSIS MACHINE FOR PERITONEAL DIALYSIS DELIVERY AND/OR INSTALLATION CHARGES FOR E1600 HEMODIALYSIS EQUIPMENT REVERSE OSMOSIS WATER PURIFICATION SYSTEM, FOR E1610 HEMODIALYSIS DEIONIZER WATER PURIFICATION SYSTEM, FOR E1615 HEMODIALYSIS E1620 BLOOD PUMP FOR HEMODIALYSIS, REPLACEMENT E1625 WATER SOFTENING SYSTEM, FOR HEMODIALYSIS E1630 RECIPROCATING PERITONEAL DIALYSIS SYSTEM E1632 WEARABLE ARTIFICIAL KIDNEY, EACH E1634 PERITONEAL DIALYSIS CLAMPS, EACH E1635 COMPACT (PORTABLE) TRAVEL HEMODIALYZER SYSTEM E1636 SORBENT CARTRIDGES, FOR HEMODIALYSIS, PER 10 E1637 HEMOSTATS, EACH E1639 SCALE, EACH E1699 DIALYSIS EQUIPMENT, NOT OTHERWISE SPECIFIED